2015 in review: Policy, politics, and payment issues in the nephrology market

Physicians, where art thou?

We opened in January of this year asking NN&I readers what it would take to make nephrology exciting again. New reports from the health care industry indicated that the independent nephrologist was on the endangered species list because economic strife was forcing them to merge with larger practices. And, data from the American Society of Nephrology suggested that even finding individuals interested in taking up the profession was becoming difficult. Fellowship slots were being left vacant.

With ASN presenting a third report on physician work force at its annual meeting last month, little has changed to move the needle despite efforts by ASN, the Renal Physicians Association, and other groups to expose fellows to the importance and value of being a nephrologist.

Dugan Maddux, MD, said in a post last month that the latest ASN report "confirms an ongoing disturbing trend, with an 8% drop in new nephrology fellows in 2014and the prediction of a further drop in 2015:' That problem is compounded by the fact that training schools are not spread out across the country equally, and fellows want to start a practice where they live. The South and the Midwest, in particular, are in need of help.

Wish Upon A Star (the more stars the better)

If you can't beat them, brag about them.

January marked the launch of the star rating system for the renal community. The Centers for Medicare & Medicaid Services released the new star ratings for dialysis clinics after six months of protests and raucous debate about the methodology. CMS had agreed to a three-month delay prior to the January 15 launch, but the renal community's hope that things would change went unfulfilled.

Begrudgingly, renal providers have accepted the ratings; DaVita Kidney Care, in fact, who voiced its opposition like all providers, now points out that it has the most five-star clinics in the country.

To its credit, CMS has taken time to meet with providers and seems willing to hear about making adjustments. We'll see if consumers-who the star system was created for in the first place-put them to use in 2016.

Give me on A! Give me o C! Give me on 0!

It didn't look like the Comprehensive ESRD Care model would see the light of day in early 2015. CMS had proposed a launch a year earlier after unveiling the details of the five-year demonstration in February 2013. Many discussions and rule changes later-induced by a general lack of enthusiasm from providers about taking on the risk that CMS was expecting-the agency looked for a new launch date of January. That stretched to July and finally, in October, the start pistol was fired. The final tally was three sites each from DaVita Kidney Care and Dialysis Clinic Inc., six from Fresenius Medical Care, and one from Rogesin Institute, the demonstration's sole small dialysis organization. Patients in the states of New Jersey, South Carolina, North Carolina, Texas, New York, Illinois, Tennessee, Arizona, Florida, Pennsylvania, and California will be part of the demonstration.

Physicians, measure thy quality

The sustainable growth rate was like the wart that came back every spring. No matter how hard you try to get rid of it-burn it, cut it, scrape it off-it would return. After years of being attacked from all sides, Congress finally buried the antiquated formula for determining Medicare physician pay. It wasn't cheap-its replacement is a 10-year plan that will cost

$131 billion. But what the Merit-Based Incentive Payment System, or MIPS, will do by 2019 is tie physician pay to qual

ity. Nephrologists, for the first time, will be able to influence their pay based on how well they do on quality measures, similar to the Quality Incentive Program that dialysis clinics are subjected to each year. It will put everyone on the same page-hopefully, with the chapter ending on a good note for patients who want good quality care.

Transplant by the numbers

If you believe that quantity and quality have a connection, you would want to get your next kidney transplant at the University of California San Francisco.

Based on an annual ranking published in NN&I each year, the hospital has done the most kidney transplants in the United States since 2009. NN&I uses data from the United Network for Organ Sharing's Organ Procurement and Transplant Network to rank the 50 busiest centers.

UCSF's program has grown from 328 kidney and kidneypancreas transplants in 2009 to 354 in 2014. But competitors are closing in: Jackson Memorial Hospital was only one transplant behind in the 2014 ranking.

What's in a (drug) name?

Keryx Pharmaceuticals was preparing to make the big announcement: its IPO was ready to launch with its new phosphate binder recently approved by the US Food and Drug Administration. One problem: the FDA suddenly decided it didn't like the name Zerenex-because it was too close to the name of another drug in a different category. After a few stressful days, Keryx came up with an answer: Auryxia.

That problem was solved, but Keryx would face another

one on the launch of its IPO: investors got confused over the requirement that nephrologists would need to check iron levels in patients' blood to make sure that Auryxia, which reduces iron requirements, was working effectively. By the time that Keryx officials clarified the issue it was too late: the company IPO got off to a rocky start and the stock price has dived from a high of $15 in January to a low of $3.04 in October.t It closed at $4.88 on Nov. 12.

The company announced in September it had won European Commission approval for its binder, called Fexeric, to treat hyperphosphatemia in dialysis and pre-dialysis patients.

Other drug products and treatments approved in 2015 for the dialysis and transplant community include:

Veltassa (hyperkalemia), from Relypsa Inc.

Triferic (iron supplement), from Rockwell International

Envarsus XR (immunosuppressant), from Veloxis Pharmaceuticals

Lixelle Beta 2-microglobulin apheresis column (dialysisrelated amyloidosis), from Kaneka Pharma America

-by Mark Neumann